NCT04313647

Brief Summary

Exosomes are naturally occurring nanosized vesicles and comprised of natural lipid bilayers with the abundance of adhesive proteins that readily interact with cellular membranes. These vesicles have a content that includes cytokines and growth factors, signaling lipids, mRNAs, and regulatory miRNAs. Exosomes are involved in cell-to-cell communication, cell signaling, and altering cell or tissue metabolism at short or long distances in the body, and can influence tissue responses to injury, infection, and disease. Experimental studies have demonstrated that mesenchymal stem cells (MSCs) or their exosomes (MSCs-Exo) significantly reduced lung inflammation and pathological impairment resulting from different types of lung injury. In addition, macrophage phagocytosis, bacterial killing and outcome were improved. It is highly likely that MSCs-Exo have the similar therapeutic effect on inoculation pneumonia as MSCs themselves. This clinical study will be performed to evaluate the safety and tolerance of aerosol inhalation of the exosomes derived from allogenic adipose mesenchymal stem cells (MSCs-Exo) in healthy volunteers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Mar 2020

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 12, 2020

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 17, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 18, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
1 year until next milestone

Results Posted

Study results publicly available

August 4, 2021

Completed
Last Updated

August 4, 2021

Status Verified

May 1, 2021

Enrollment Period

2 months

First QC Date

March 17, 2020

Results QC Date

December 16, 2020

Last Update Submit

July 13, 2021

Conditions

Healthy

Keywords

mesenchymal stem cellsexosomesmesh nebulizer

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Adverse Reaction (AE) and Severe Adverse Reaction (SAE)

    Safety evaluation within 7 days after first treatment, including frequency of adverse reaction (AE) and severe adverse reaction (SAE)

    from Day 0 to Day 7

Other Outcomes (2)

  • Alanine Aminotransferase (ALT) (IU/L)

    day 0 and day 7

  • Creatinine (Cr) (μmol/L)

    day 0 and day 7

Study Arms (5)

1X level

EXPERIMENTAL

Aerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (2.0\*10\^8 nano vesicles/3 ml)

Biological: 1X level of MSCs-Exo

2X level

EXPERIMENTAL

Aerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (4.0\*10\^8 nano vesicles/3 ml)

Biological: 2X level of MSCs-Exo

4X level

EXPERIMENTAL

Aerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (8.0\*10\^8 nano vesicles/3 ml)

Biological: 4X level of MSCs-Exo

6X level

EXPERIMENTAL

Aerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (12.0\*10\^8 nano vesicles/3 ml)

Biological: 6X level of MSCs-Exo

8X level

EXPERIMENTAL

Aerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (16.0\*10\^8 nano vesicles/3 ml)

Biological: 8X level of MSCs-Exo

Interventions

1X level of MSCs-ExoBIOLOGICAL

Once aerosol inhalation of MSCs-derived exosomes (2.0\*10\^8 nano vesicles/3 ml)

1X level
2X level of MSCs-ExoBIOLOGICAL

Once aerosol inhalation of MSCs-derived exosomes (4.0\*10\^8 nano vesicles/3 ml)

2X level
4X level of MSCs-ExoBIOLOGICAL

Once aerosol inhalation of MSCs-derived exosomes (8.0\*10\^8 nano vesicles/3 ml)

4X level
6X level of MSCs-ExoBIOLOGICAL

Once aerosol inhalation of MSCs-derived exosomes (12.0\*10\^8 nano vesicles/3 ml)

6X level
8X level of MSCs-ExoBIOLOGICAL

Once aerosol inhalation of MSCs-derived exosomes (16.0\*10\^8 nano vesicles/3 ml)

8X level

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteers.
  • Age: 19-45, males and females.
  • The weight is within ± 10% of the standard weight \[standard weight (kg) = 0.7 × (height cm-80)\].
  • Examination indices of heart, liver, kidney and blood are all within the normal range.
  • According to Good Clinical Practice (GCP), volunteers who understand and voluntarily sign the consent form before this study.

You may not qualify if:

  • Women in pregnancy or lactation.
  • Primary diseases of important organs.
  • Mentally or physically disabled patients.
  • Suspected or definite history of alcohol and drug abuse.
  • According to the investigator's judgment, there is a low possibility of enrollment (such as frailty, etc.).
  • Volunteers who are allergic to the components of this medicine, or have a history of allergies to two or more drugs or food.
  • Volunteers who have diseases (such as insomnia) and are using other preventive and therapeutic drugs before this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

Related Publications (1)

  • Shi MM, Yang QY, Monsel A, Yan JY, Dai CX, Zhao JY, Shi GC, Zhou M, Zhu XM, Li SK, Li P, Wang J, Li M, Lei JG, Xu D, Zhu YG, Qu JM. Preclinical efficacy and clinical safety of clinical-grade nebulized allogenic adipose mesenchymal stromal cells-derived extracellular vesicles. J Extracell Vesicles. 2021 Aug;10(10):e12134. doi: 10.1002/jev2.12134. Epub 2021 Aug 14.

    PMID: 34429860DERIVED

Results Point of Contact

Title
Dr. Qu
Organization
Ruijin Hospital , Shanghai Jiao Tong University School of Medicine
jmqu0906@163.com
(+86)2164370045

Study Officials

  • Jieming Qu, MD,PhD

    Ruijin Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: MSCs-exosomes
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2020

First Posted

March 18, 2020

Study Start

March 12, 2020

Primary Completion

April 30, 2020

Study Completion

July 31, 2020

Last Updated

August 4, 2021

Results First Posted

August 4, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

No plan to make individual participant data available to other researchers.

Locations

CN(1)